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Conversion to Embeda With Rescue Trial

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NCT01179191

Last updated on January 19, 2020
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FOR MORE INFORMATION
Study Location
Adamsville Family Medicine
Adamsville, Alabama, 35005 United States
See other locations
Contact
1-800-718-1021
ClinicalTrials.gov_I[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Disease, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Be able to read, speak and understand English

- Have chronic moderate to severe pain for at least 3 months

- Require around the clock opioid medication for the relief of pain

- Have been taking a daily opioid for at least 30 days prior to starting the study

- Be able to be safely switched to a different pain medication

- Be practicing acceptable birth control methods for female patients of childbearing
potential

- Be willing to participate in the study and able to comply with study procedures

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Be currently diagnosed with or participating in and/or seeking treatment for opioid
and/or alcohol abuse

- Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids

- Be currently taking tramadol and/or extended release morphine products

- Have respiratory depression

- Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease

- Have migraines as your main source of pain

- Have any form of bowel obstruction

- Be pregnant or breast feeding

- Have had 2 or more surgeries for low back pain

- Be planning a major surgery during the study

- Be staying in a hospital or nursing home

- Be planning to have steroid injections for your chronic pain during the study

- Have a life expectancy of less than 2 months

NCT01179191
Pfizer
Terminated
Conversion to Embeda With Rescue Trial

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[email protected]

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Descriptive Information
Brief Title  ICMJE Conversion to Embeda With Rescue Trial
Official Title  ICMJE A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
Brief Summary The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
Detailed Description The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Disease
  • Pain
Intervention  ICMJE Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Study Arms  ICMJE Experimental: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 30, 2012) 		684
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010) 		1300
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be able to read, speak and understand English
  • Have chronic moderate to severe pain for at least 3 months
  • Require around the clock opioid medication for the relief of pain
  • Have been taking a daily opioid for at least 30 days prior to starting the study
  • Be able to be safely switched to a different pain medication
  • Be practicing acceptable birth control methods for female patients of childbearing potential
  • Be willing to participate in the study and able to comply with study procedures

Exclusion Criteria:

  • Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
  • Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
  • Be currently taking tramadol and/or extended release morphine products
  • Have respiratory depression
  • Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
  • Have migraines as your main source of pain
  • Have any form of bowel obstruction
  • Be pregnant or breast feeding
  • Have had 2 or more surgeries for low back pain
  • Be planning a major surgery during the study
  • Be staying in a hospital or nursing home
  • Be planning to have steroid injections for your chronic pain during the study
  • Have a life expectancy of less than 2 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01179191
Other Study ID Numbers  ICMJE ALO-01-10-4003
B4541001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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